🇺🇸 Xyrem in United States

FDA authorised Xyrem on 17 July 2002 · 31,128 US adverse-event reports

Marketing authorisations

FDA — authorised 17 July 2002

  • Application: NDA021196
  • Marketing authorisation holder: JAZZ PHARMS
  • Status: supplemented

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Nausea — 4,313 reports (13.86%)
  2. Anxiety — 3,669 reports (11.79%)
  3. Somnolence — 3,186 reports (10.24%)
  4. Depression — 3,048 reports (9.79%)
  5. Headache — 2,951 reports (9.48%)
  6. Feeling Abnormal — 2,926 reports (9.4%)
  7. Condition Aggravated — 2,861 reports (9.19%)
  8. Weight Decreased — 2,831 reports (9.09%)
  9. Fatigue — 2,701 reports (8.68%)
  10. Dizziness — 2,642 reports (8.49%)

Source database →

Xyrem in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Xyrem approved in United States?

Yes. FDA authorised it on 17 July 2002; FDA has authorised it.

Who is the marketing authorisation holder for Xyrem in United States?

JAZZ PHARMS holds the US marketing authorisation.